Is a Medical Device Manufacturer a “Health Care Provider” in Texas?

In Verticor, Ltd. v. Wood, an appellate court considered whether personal injury lawsuits against a medical device manufacturer count as health care liability claims for the purposes of the Texas Medical Liability Act (TMLA). The case arose when a surgeon treated a herniated disc in the plaintiff’s lumbar spine by using a device called the “Eclipse Sphere,” which was manufactured by the defendant. After suffering complications, the plaintiff sued the doctor and the manufacturer.

The plaintiff argued that the surgeon had used the device in a non-fusion procedure, although it was only approved by the FDA for use in fusion procedures in the lumbar region. The FDA had also required that the device’s packaging and manuals include a warning about how its safety in non-fusion procedures hadn’t been established yet.

The plaintiff argued that the doctor was professionally and grossly negligent in using the device in an off-label, experimental fashion and not getting his informed consent for it. He also claimed that the manufacturer had solicited the off-label use, alleging strict liability theories of failure to warn, negligent marketing, a breach of the implied warranty of merchantability, and fraud. The manufacturer claimed as an affirmative defense that it is a health care provider as defined by the TMLA.

The plaintiff moved for partial summary judgment on this issue. He sought a ruling that the manufacturer was not a health care provider. The manufacturer noted that, although there were no doctors or nurses in the company, it was a business that was licensed to provide health care, based on its license issued by the Texas Department of State Health Services. The lower court granted the plaintiff’s motion for partial summary judgment.

The manufacturer asked the court to reconsider but provided no new evidence in support of its claims, and it also filed a motion to dismiss on the basis that the plaintiff hadn’t served an expert report. These motions were denied, and the manufacturer appealed. The manufacturer argued that the court was required to grant its motion to dismiss, based on the plaintiff’s failure to serve an expert report.

The appellate court noted that there were several procedural requirements in the TMLA, which defines health care liability claims as those pursuing compensation from a health care provider or physician for a deviation from accepted standards of medical care that proximately caused an injury or death. The TMLA provides that only lawsuits against doctors and health care providers are considered health care liability claims. The plaintiff had served an expert report as required by the TMLA in connection with the surgeon, but not with respect to the medical device manufacturer.

The appellate court explained that unless it could establish itself as a health care provider as defined by the TMLA, the manufacturer could not prevail. The manufacturer had to prove that it was licensed by Texas to provide health care. The appellate court explained that the manufacturer had admitted it had no involvement in the plaintiff’s care or treatment beyond manufacturing a device used in surgery. Under the TMLA, “health care” meant an act or treatment furnished by a health care provider on behalf of a patient during medical care, treatment, or confinement. The appellate court found that the manufacturer couldn’t meet the definitions of the TMLA, based on either its plain meaning or its legislative history. The appellate court affirmed the lower court’s order denying the manufacturer’s motion to dismiss.

If you are hurt due to medical malpractice or a defective medical device, the experienced San Antonio attorneys at Carabin & Shaw may be able to represent you and develop a sound strategy for handling your case. Call our office for more information at 1-800-862-1260.